Phase 4
Completed N=144
A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation
Anesthesia
Source: ClinicalTrials.gov NCT03255824 ↗
Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Respiratory Events Requiring Intervention — 17; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and 3) no significant hemodynamic or respiratory changes when compared to a sedation combination of midazolam, fentanyl and propofol for sedation during third molar surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Events Requiring Intervention |
17; 2 | — |
| SECONDARY Reaction to Administration of Local Anesthesia |
3.9; 4.2 | — |
| SECONDARY Patient Satisfaction |
93.5; 86.6 | — |
| SECONDARY Surgeon Satisfaction - Survey |
2.8; 2.9 | — |
| SECONDARY Cooperation Scale |
2.07; 1.47 | — |
| SECONDARY Hemodynamic Stability - Heart Rate |
77; 62 | — |
| SECONDARY Hemodynamic Stability - Blood Pressure |
78; 88 | — |
| SECONDARY Respiratory Depression - Respiratory Rate |
18; 18 | — |
| SECONDARY Respiratory Depression - Oxygen Saturation |
98.7; 98.9 | — |
| SECONDARY Postoperative Recovery Time - Duration of Procedure |
24.2; 22.1 | — |
| SECONDARY Postoperative Recovery Time - Ambulation |
10.8; 11.6 | — |
| SECONDARY Postoperative Recovery Time - Time to Discharge |
26.5; 29.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction
- ASA Class I or II
- English-speaking and Spanish-speaking subjects
Exclusion Criteria
- ASA Class III or higher
- Patients taking alpha-2 agonists or benzodiazepines
- Allergy or drug reaction to any of the drugs used in this study (benzodiazepines, opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)
- BMI greater than 30
- History of or current substance abuse or alcoholism
- History of mood-altering medications, tranquilizers, or antidepressants.
- Pregnant females
Data sourced from ClinicalTrials.gov (NCT03255824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.